Phase II study of new risk classification and high-dose chemotherapy for medulloblastoma

JRCT ID: jRCTs051200021

Registered date:28/05/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Medulloblastoma
• Date of first enrollment: 15/06/2020
• Target sample size: 229
• Study type: Interventional

Intervention(s)

With the introduction of new risk classification that combines the molecular classification and the conventional risk factor (M stage), three risk groups for ages 4 and older (low risk (LR), standard risk (SR) and high risk (HR)) and two risk groups for age less than 4 years (standard risk (SR) and high risk (HR)) are defined.

In all patients, intrathecal chemotherapy with MTX (IT-MTX) is performed concomitantly with chemotherapy.

For all risk groups patients less than 4 years old, induction chemotherapy intensified with high-dose MTX and following high-dose chemotherapy with thiotepa and melphalan (HDC-TM) is planned. For all HR patients and SR patients with residual tumor after HDC-TM, 50.4 Gy of local irradiation and maintenance therapy with IT-MTX are added.

For all patients aged 4 years or older, induction chemotherapy with IT-MTX and following chemoradiotherapy including craniospinal irradiation (CSI) is planned. The doses of CSI are 18 Gy for LR and SR and 23.4 Gy for HR. Following chemoradiotherapy, HDC-TM is added for SR and HR patients. The dose of local irradiation is 50.4 Gy (54 Gy if residual before irradiation) for all risk groups.

Outcome(s)

Primary Outcome

Age greater than or equal to 4 years without metastases: 5yr progression-free survival
Age greater than or equal to 4 years with metastases: 5yr progression-free survival
Age less than 4 years without metastases: 3yr progression-free survival
Age less than 4 years with metastases: 3yr progression-free survival

Secondary Outcome

3yr and 5 yr overall survival
Response rate
Pattern of relapse
Rate of adverse effect (CTCAE grade 3-5)
Neurocognitive function (2yr and 5yr)
Rate of secondary neoplasms (2yr and 5yr)
Rate of endocrine disorders (2yr and 5yr)
Rate of cerebrovascular event (2yr and 5yr)
Confirmation rate of risk classification based on molecular classification

Key inclusion & exclusion criteria

• Age minimum: >=
• Age maximum: < 30age old
• Gender: Both

Include criteria

1) Locally diagnosed as medulloblastoma after tumor resection or biopsy
2) Protocol treatment can be started within 6 weeks after surgery
3) Less than 30 years
4) No prior radiation or chemotherapy
5) ECOG Performance Status (PS) is 3 or less

Exclude criteria

1) Active double cancer (synchronous double cancer and metachronous double cancer with disease-free period of 5 years or less).
2) Complicated with extracranial metastasis (M4).
3) Complicated heart disease requiring treatment.
4) You are pregnant or nursing.

Related Information

• Primary Sponsor: Hara Junichi
• Secondary Sponsor: Japan Agency for Medical Research and Development
• Secondary ID(s): Nil known